CASE 1320: RAI Uptake and Serum Prolactin in Thyroid Cancer

NCT04495985 | Active Not Recruiting

• 1 other identifier: IRB 20-488
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Radioactive iodine (RAI) is a radioisotope used to ablate thyroid gland remnant after thyroidectomy in patients diagnosed with differentiated thyroid carcinoma (DTC). A whole body scan (WBS) is performed to not only evaluate for iodine uptake by the native thyroid tissue but also to observe for uptake in other areas of the body, which could be physiological or indicative of iodide-avid metastases. Research has shown a correlation between breast cancer and thyroid cancer. Patients with DTC have been found to have elevated levels of serum prolactin, which could lead to mammary gland dysfunction. In patients with DTC undergoing RAI scanning or therapy, it has been previously observed that patients prepared by thyroid hormone withdrawal have significantly higher breast uptake on whole body scan compared to those prepared by rh-TSH. Considering the impact of prolactin on breast tissue, this study aims to correlate these findings with the lab values and the method of preparation. Accordingly, the research question is as follows: does the method of WBS preparation impact prolactin levels and how does that correlate with breast uptake in patients with DTC undergoing RAI WBS?

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• Breast uptake of I-131 on whole body radioactive iodine scan

  Breast uptake of I-131 on whole body radioactive iodine scan

  10 days after treatment

Secondary Outcomes (4)

• Change in serum prolactin concentration

  6 weeks

• Serum prolactin concentration

  3 days

• Prolactin level and breast uptake of I-131

  Day 46 of thyroid hormone withdrawal group

• Prolactin level and breast uptake of I-131

  Day 26 of thyrogen preparation group

Study Arms (2)

Thyrogen (rh-TSH)

Group 1: Female patients prepared for radioactive iodine treatment by rh-TSH (Thyrogen)

Withdrawal from thyroid hormone

Group 2: Female patients prepared for radioactive iodine treatment by withdrawal from thyroid hormones

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Group 1: Female patients with differential thyroid cancer prepared for radioactive iodine whole body scan by withdrawal from thyroid hormones Group 2: Female patients with differential thyroid cancer prepared for radioactive iodine whole body scan by rh-TSH.

You may qualify if:

• Female patients with diagnosis of differentiated thyroid carcinoma who have had thyroidectomy performed previously
• Patients able to understand and sign informed consent for imaging
• Patients already scheduled to undergo radioactive iodine whole body scanning (RAI WBS)

You may not qualify if:

• Males
• Patients with a history of breast cancer
• Patients with a known history of hyperprolactinemia
• Patients receiving medications known to raise serum prolactin

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Alexandra Mikhael, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: August 3, 2020
• Study Start: July 14, 2020
• Primary Completion: July 27, 2022
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)